Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population

Alcon

Status

Completed

Conditions

Presbyopia

Aphakia

Treatments

Procedure: Cataract surgery

Device: AcrySof IQ PanOptix Presbyopia Correcting IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT04755231

ILH297-C004

Details and patient eligibility

About

The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.

Full description

In this clinical study, subjects will be implanted with the PanOptix IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 14 months. This study will be conducted in China.

Enrollment

181 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Able to comprehend and sign an informed consent form;
Able to complete all study visits required in the protocol;
Chinese; diagnosed with cataracts in both eyes;
Planned bilateral cataract removal by routine phacoemulsification;
Pre-operative regular corneal astigmatism of less than 1.0 diopter (D);
Pre-operative best corrected distance visual acuity (BCDVA) worse than or equal to 0.3 LogMAR in each eye;
Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better in both eyes based on the investigator expert medical opinion.
Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;
Clinically significant corneal diseases;
Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;
Previous intraocular or corneal surgery;
Pregnancy or lactation during study or planning to be pregnant/lactating;
Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject;
Other planned ocular surgical procedures;
Patients who desire monovision correction.
Other protocol-specified exclusion criteria may apply.